Significance and Use 5.1 Application of the approach described within this guide is intended to satisfy international regulatory expectations in ensuring that SUS are fit for their intended use and to satisfy requirements for sourcing, supply, design, specification, installation, operation, and performance. 5.2 The approach described in this guide applies concepts and principles introduced in the FDA initiative, Pharmaceutical cGMP’s for the 21st Century – A Risk-Based Approach. It supports and is consistent with the framework described in FDA Guidance for Industry, Process Validation: General Principles and Practices, in ICH Q7, ICH Q8 (R2), ICH Q9, and ICH Q10. 5.3 This guide includes concepts developed in the PDA Technical Report No. 66. 5.4 This guide may be used independently or in conjunction with other ASTM Committee E55 proposed standards to be published by ASTM International. 5.5 Specific standard practices about extractables, leachables, particulate matter, and integrity testing/leak detection, biocompatibility, and raw materials as available should be used by suppliers and end users and applied to their own manufacturing process facilities.Scope 1.1 This guide is intended as a complement to Guide E2500. 1.2 This guide is applicable to the range of manufacturing systems described in Guide E2500, specifically all elements of single-use systems, or hybrids of single-use and traditional components, used for the manufacturing of pharmaceutical and biopharmaceutical products, including: materials of construction, components, assembly, manifolds, supporting utilities, associated process monitoring and control systems, automation systems, and controlled environment that have the potential to affect product quality and patient safety. 1.3 This guide is applicable for the implementation of changes to manufacturing system design for existing systems. It may be used for continuous improvement and changes in operation from clinical through to commercial scale. 1.4 For brevity, single-use systems are referred to as SUS throughout the rest of this guide. 1.5 The approach may be applied by the end user, the supplier of SUS, and raw materials sub-suppliers further back in the supply chain. 1.6 This guide is not intended to apply to the use of single-use technology for packaging, primary containers, combination products (products composed of any combination of a drug, device, or biological product) or devices. 1.7 This guide does not address specific local requirements, which remain the responsibility of the end user. 1.8 This guide does not address employee health and safety, environmental, nor other good engineering and manufacturing practices (GXP) requirements. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
